China Updates Medical Device Trial Guidelines

In the document, CFDA covered general principles of device trials for registration studies intended for obtaining regulatory approvals, as well as preparation criteria, informed consent, clinical trial protocols, and management of study device and source documents.

The Chinese medical device market and regulatory landscape has undergone a myriad of changes in the past few years.

China’s previous rules for clinical trials under the Provision on Medical Device Trials of 2004 will be replaced by these new requirements.

The update does not cover in vitro diagnostic reagents that are classified as medical devices

Patient safety protections include enhanced sponsor monitoring requirements and additional requirements for patient informed consent. The guidelines provide stricter sponsor monitoring requirements and strengthen the role of ethics committees in study design and monitoring. The additional requirements for patient informed consent include the types of information that must be provided as well as acceptable methods for obtaining informed consent.

As China’s role as an exporter of medical products grows, the United States Food and Drug Administration (FDA) has strengthened its relationship with Chinese regulators. Among many initiatives, FDA has trained hundreds of Chinese inspectors in areas that include inspecting for good manufacturing practices and assessing the quality of data from sites that conduct clinical trials